Andhra Launches First CDSCO-Approved Medical Device Audit Body

KCS is one of only 14 notified bodies in India and is currently the only operational entity in Andhra Pradesh and Telangana.

Andhra Pradesh has launched its first-ever Central Drugs Standard Control Organisation (CDSCO) - a notified auditing body for medical device manufacturers.

KIHT Certification Services (KCS) has been formally approved to carry out regulatory audits for Class A and Class B medical device manufacturing units.

KCS is one of only 14 notified bodies in India and is currently the only operational entity in Andhra Pradesh and Telangana.

Operating under the Kalam Institute of Health Technology (KIHT), KCS is based at the Andhra Pradesh MedTech Zone (AMTZ) campus in Visakhapatnam.

KIHT, founded in 2017 with support from the Department of Biotechnology, focuses on advancing medical technology through research, policy initiatives, and collaborations with industry.

KCS, established in April 2022, is accredited by the National Accreditation Board for Certification Bodies (NABCB) under ISO/IEC 17021-1:2015 and IAF MD 9:2023 standards.

It provides a wide range of services, including ISO 13485 certification, audits of quality management systems, risk management training, and consultancy for CE marking.

Officials at Andhra MedTech Zone stated that the availability of a local auditing body is expected to benefit medical device manufacturers, particularly MSMEs, by speeding up regulatory compliance processes and minimizing the need for audits from outside the region.

They also emphasized that this milestone highlights Andhra Pradesh’s growing role in strengthening India’s MedTech ecosystem.

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